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Heart patients sue Medtronic over recalled device

(AP) - A man who claims he received 47 unneeded
jolts from his implanted defibrillator is suing Medtronic over the broken wires the company is recalling.

Plaintiffs Leonard Stavish and Kelly Luisi seek class-action
status in U.S. District Court in Minneapolis as representatives of
people they say were hurt.

The lawsuit's allegations include emotional distress and
negligence, and it seeks restitution, disgorgement of profits, and
punitive damages.

Medtronic Inc., maker of pacemakers and other heart devices, has
acknowledged that wires connecting its implantable defibrillators
to patient hearts break more often than it expected. It said five
deaths may be linked to the broken wires. Medtronic said some
235,000 people have the Sprint Fidelis lead wires.

“We would expect the litigation floodgates to open over the
current recall.”

Attorneys for Stavish claim his defibrillator had to be removed
because he got 47 jolts he didn't need. They said the device was
replaced with another defibrillator and a new set of Sprint Fidelis
wires.

The lawsuit also said Luisi went to the emergency room after
experiencing "frightening episodes of unnecessary shocks."

At the
hospital, Luisi's defibrillator "began delivering unnecessary
shocks over and over again," after someone from Fridley-based
Medtronic used an instrument to check her device, according to the
lawsuit. The lead was removed a month later.

Removing the leads can be dangerous because it may tear at scar
tissue that builds up around the wires. The lawsuit said Luisi was
forced to have her lead removed, "scarring her already fragile
heart, and forcing her to undergo additional and unnecessary
complicated surgery."

Hunter J. Shkolnik, an attorney for Stavish and Luisi, said they
decided on Friday to file the lawsuit, and he said he has 25 more
clients who will sue in coming days as their complaints are written
up. He said he believes Medtronic disclosed the lead problems late
Sunday because it knew the lawsuits were on the way.

Medtronic spokesman Rob Clark said the company did not have any
immediate comment on the lawsuit. He denied the lawsuit affected
the timing of Medtronic's disclosure.

"We made our decision and we moved forward based on our concern
for patient safety, and our commitment to patient well-being," he
said.

Carol Levenson, an analyst at Gimme Credit, wrote in a note on
Tuesday that a 2005 Medtronic recall over defibrillator battery
failures, which Levenson said was less severe than the new one,
brought more than 1,000 personal injury cases.

"We would expect the litigation floodgates to open over the
current recall as well," she wrote.